Feb 1, 2021

BME- 178

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• A set of quality control practices and procedures incorporated into the design and development process
• Control the design process to assure that device specifications meet:
○ User needs
○ Intended use
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• 44% of voluntary recalls from October 1983 through September 1989 --> may have been prevented by adequate design
controls.
• 90% of all software related device failures from 1983 through 1989 were due to design related error.
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• Safe Medical Device Act of 1990 authorized FDA to add Design Controls to the current Good Manufacturing
Practice (cGMP) requirements for devices.
• The QS Regulation became effective on June 1, 1997, replacing the 1978 GMP for medical devices.
• Preamble to the QS regulation: extremely important for understanding Design Controls.
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• Design History File (DHF) --> compilation of records which describes the design history of a finished device.
• Device Master Record (DMR) --> compilation of records containing the procedures and specifications for a finished
device.
• Device History Record (DHR) --> compilation of records containing the production history of a finished device.
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• Design controls apply to:
○ All Class II and Class III devices
○ The following Class I devices:
1. Devices automated with computer software
2. Tracheobronchial suction catheters
3. Surgeon's gloves
4. Protective restraints
5. Manual radionuclide applicator system
6. Radionuclide teletherapy source
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• Design control is a Key Subsystem of Quality System
• Quality System (QS) Regulations: 21CFR 820
○ Management controls
○ Design controls
○ Production and process controls
○ Corrective and preventive actions
○ Documents, Records, & Change Control
○ Material Control
○ Facility & Equipment Control

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BME 178

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• Establish procedures to control device design:
○ Define
○ Document
○ Implement
• Maintain procedures to control device design:
○ Review
○ Approve
○ Update
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• Establish, maintain and document Planning:
○ Describe or reference design and development activities
○ Identify, describe, and define interfaces, responsibilities, and activities impacting device design
○ Review, document, approve, and update as developments and changes evolve
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• Design input means the physical and performance characteristics of a device that are used as a basis for device
design.
• Establish and maintain procedures for design input:
○ Ensure requirements are appropriate by addressing user needs and intended use in terms of measurable
○ Address incomplete, ambiguous, or conflicting requirements
○ Document, review, and approve input requirements
• Sources of Design Input:
○ Standards
○ Focus groups
○ Customers
○ MDRs
○ CAPA
○ Service reports
○ Complaints
○ Marketing surveys
○ Sales feedback
○ Competitors’ products
• Examples of Design Input
○ Device functions • Physical characteristics • Performance • Safety • Reliability • Standards • Regulatory
requirements • Human factors • Labeling & packaging • Maintenance • Sterilization • Compatibility with
other devices • Environmental limits
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• Design output means the results of a design effort at each design phase and at the end of the total design effort
• Design outputs are the design specifications which must meet design input requirements, as confirmed during
design Verification and Validation and ensured during design Review
• • Design Outputs are included in premarket submissions as Device Specifications.
• The finished design output is the basis for the Device Master Record (DMR).
• The total finished design output consists of the device, its packaging, labeling, and the Device Master Record
(DMR).
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• Design Review means a documented, comprehensive, systematic examination to:
○ Evaluate adequacy of the design requirements.
○ Evaluate capability of the design to meet requirements.
○ Identify any problems.
• Plan and conduct formal documented Design Reviews of design results at appropriate stages
• Document results of design review in Design History File (DHF)
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BME-178

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• Verification means confirmation by examination and provision of objective evidence that output meets input
requirements.
• Establish and maintain procedures for Design Verification:
○ Confirm through measurable means (e.g., test reports, etc.).
○ Review, approve and document in Design History File (DHF).
• Many test reports associated with Design Verification are included in premarket submissions:
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• Design Validation means establishing by objective evidence that specifications(specified requirements) conform
with user needs and intended use(s).
• Establish and maintain procedures for Design Validation:
○ Under defined operating conditions
○ On initial production units, lots, or batches (or their equivalents)
○ Under actual or simulated use conditions
• Failure to establish and maintain adequate procedures for Validating the device design and Risk Analysis, where
appropriate, as required by 21 CFR 820.30(g)
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• Establish and maintain procedures to ensure correct Design Transfer into production specifications
• Is the Design accurately transferred to Production?
• Although Design Transfer happens throughout, there frequently is a final stage of development intended to ensure
all outputs are adequately transferred
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• Establish and maintain procedures for the identification, documentation, validation or where appropriate
verification, review, and approval of Design Changes before their implementation
• Is there a system in place to enact future changes?
• Often overlooked, but of critically importance.
• How can you improve your product if you have no system for change?
• Depending on the scope and impact of the change, the change may require:
○ A new 510(k)
○ A new PMA, a PMA supplement, or a PMA 30-Day Notice
○ A new IDE or an IDE supplement
• Changes must be communicated to FDA if the device is under premarket review or IDE review
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• Design History File (DHF) means a compilation of records which describes the design history of a finished device.
• It is a summation record of all Design actions, from start to transfer, including changes
• Establish and maintain a design history file for each type of device
• Include in the DHF or reference records information necessary to demonstrate that the design was developed in
accordance with the Design Plan and Quality Systems requirements
• Like the Quality Systems regulations themselves, Design Control should be viewed and understood as a system – a
subsystem within the main System.
• Processes –->A set of quality control practices and procedures incorporated into the design and development process
• Goal--> Control the design process to assure that device specifications meet:
○ User needs
○ Intended use

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